COMMISSION OF THE EUROPEAN COMMUNITIES

REPORTS

OF THE SCIENTIFIC COMMITTEE

FOK FOOD

Manuscript finished in December 1978

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Composition of the Scientific Committee for Food

Messrs P. Elias

R. Franck

F. Fairweather

H. Gounelle de Pontanel

L. Gatti

F. Hill

A. Lafontaine

P. Marquardt (vice-chairman)

A. Mariani

E. Poulsen (vice-chairman)

P. Schuller

R. Truhaut (chairman)

G.J. Van Esch

3. Weedon

R. Wennig

3

RZX'ORT OF TXE SCIENTIFIC COXJITTEE FaR FOOD

ON

B'iULSIFIEKS,STABILIZ~:RS, TdICXEKdRS Aim

GELLING ACIENTS

(Opinion expressed 30 Novernller 1975)

TERMS OF REFERENCE

To review certain aspects of the Directive on Emulsifiers, Stabilizers, Thickeners and Gelling Agents for use in Foodstuffs', in particular the acceptability, from the point of view of safety in use, of substances listed in Annex II of the Directive.

BACKGROUND

When the Directive was agreed by the Council of Ministers in June 1974 a number of issues were left for future determination. Some substances, were separately listed in Annex II* of the Directive.

used only in a few Member States, Article 3 of the Directive permits

Member States to authorise the use of these substances in food for a period of "five years from the notification" of the Directive. This period comes to an end in June 1979, and therefore the Commission is currentiy considering whether it would be appropriate to include these substances in Annex I (substances which may be authorised in the whole community). In the case of some substances in Annex I namely E 408, E 450(c), E 460, E 480~~ E 481 and E 482, the Council requested the Commission to reexamine their acceptability during the same period. The Commission has asked the Committee for its advice.

The basic Directive also requires that purity criteria for all substances be drawn up and the Committee notes with approv 1 that such criteria have already been established for substances appearing in Annex I 3 .

During preliminary discussions of the Commission's proposals between the Commission Services and experts from Member States , questions were raised about the toxicological acceptability of some of the purity criteria and the Committee was asked for its advice on a number of points relating to:

- the identity of E 407/E 408

- the protein content of E 412

- the identity cf E 440

- the maximum molecular weight for E 466

- the acceptability of the classification of E 472

The opinions of the Committ ee on these qu estions were submi tted to the 1977 and are reprodu ted in extenso in thi s Report (Annexes 3 to 6).

Commission early in

,T'he Conl-nission has also asked the opinion of the Committee on the use of E 413 following requests by European Parliament and Economic and Social Committee members.

CURRENT REVIEW

The Commission Services requested Member States to supply up-t&ate information (toxicological, technological and usage) on the substances under discussion. These date, in the main, were supplied as summaries. The Commission Services were also able to provide data, submitted to them by the industries concerned, on a number of substances.

'74/329/%X of 18 J uric 1974, OJ I, 189 of 12.7.1974, p. 1

270/663/E~C of 25 July 1978, OJ 1, 223 of 14.8.1978, p. 7

% or easy reference to names of the substances, Annexes I anI1 II are reproduced in Annexes 1 and 2 to this Report

5 480 h as since been deleted from the Directive

7

The Committee decided that it wouid be unnecessarily cumbersome to request that all data, previously submitted to national governments, be made available to each member. However, the Committee felt unable simply to rely on summaries of data submitted to other bodies. It was agreed therefore that designated members of the Committee should examine details of different submissions in full, but that the resulting assessment could be presented in summary form to the main Committee unless there b:as a particular reason to depart from this procedure. References to all the data examined in this way are given for each substance under the appropriate heading in Annexes 3 to 7.

The Community Directiv e does not in general refer to the foodstuffs in which particular emulsifiers, stabilizers, thickeners and gelling agents may be used. Nevertheless, Article 4 of the Directive requires that the Council "shall determine as soon as possible the foodstuffs to which these substances may be added and the conditions under which they may be added", The Committee recommends that steps be taken to implement these requirements, and draws attention to the fact that any misuse of the additives discussed in this Report may lead to excessive retention of water with a reduction in the nutritional value of the food on a weight for weight basis.

The Committee therefore confined its attention mainly to establishing whether, from the point of view of safety, individual emulsifiers, stabilizer, thickeners and gelling agents were acceptable. Nevertheless it seemed desirable to indicate in the report some technological applications of which the Committee was informed although not all of these apply necessarily in the Community context. The Committee wishes to reiterate the point made in its Opinion on Fine Bakers‘ Wares, Rusks, Pastries and Biscuitsl)thatthe setting of maximum levels of use of an additive in various foods is not a purely arithmetical exercise. The desired technological results must be achieved in a way that ensures that the AD1 is unlikely to be exceeded. The Committee requests that it be kept informed by the Commission of proposals for the assignment of maximum levels of use for any food additive and be invited to comment from the point of view of safety in use,

ASSES514ENT OF TOXICOLOGICAL ACCEPTABILITY

The general criteria used in the present review for the evaluation of emulsifiers, stabilizers, thickeners and gelling agnets are comparable to those employed in the assessment of the safety of colouring matters, and are summarised in paragraph 10 of the Committee's first report on such substances 2). The Committee noted that in many instances compounds proposed for use as emulsifiers, stabilizers, thickeners and gelling agents were esters which during their metabolism hydrolysed into components for which global ADIs had been established by JECFA at various times. It wished to draw attention to these evaluations of JECFA and to the need for taking these into consideration when assigniF levels of use.

CLASSIFICATION OF EMULSIFIERS, STABILIZERS, THI.CKEi\jERS AND CELLING AGENTS

The classification used during the present review was similar to the one used for colouring matters (see paragraph 11 of the Committee's 1st report on colouring matters).

I.

II.

Substances for which an AD1 could be established and which are therefore toxicologically acceptable for use in foods within these limits

As a working principle, before a food aditive can be accepted for use in food, it is necessary to provide adequate toxicoloi+cal data. Based on these data an AD1 can be established using results obtained with the most sensitive animal species and usinp the most sensitive criterion.

Substances for which a temporan AU1 could be established an4 k'lich are toxicolo,4.call\. acceptable for use in fooc1 within these limits for a nerio4 of 3 \fears or 'j years dcpcniiinfr on the tvpes o!‘ information reouired

Not later than one year before the end of -i;he appropriate period, the Committee expects to be provided b:ith a report on the tests indicated in Annex 7 as necessary.

1) Reports of the Scientific Committee for Foo,l, 5th Series, I\la,~ 1978 2) Reports of the Scientific Committee for Food, 1st Series, December 1973

8

III.

IV.

ESrceptionally the Committee would be prepared to consider recommending the period of validity of the temporary ADI, provided it was satisfied progress had been made with the tests required.

an extension of that substantial

Substances for which an AD1 could not be established but which are nevertheless considered acceptable or temporarily acceptable for use in food

The Committee was unable to establish formal ADIs on the basis of the available toxicological information. However, some of these substances occur naturally and are consumed as part of the diet in some parts of the world. Others are used at very lorcl levels in food, or are used only in products of lovr consumption. Most of the substances are known to hydrolyse into components to which the body is already exposed, or which are of known toxicity.

Substances for which an AD1 could not be established and which are not toxicologically acceptable for use in food

Where a substance has been included in this category, the Committee believes that its use should be phased out. However, the Committee would be willing to reconsider its advice should adequate additional information become available.

Unless other requirements are stipulated with respect to particular substances the Committee believes that there is no objection to a gradual phase out over a period of 1 year or so.

Detailed comments on individual substances are given in Annex 7.

SUKMARY OF CONCLUSIONS

1. Substances for b:hich an AD1 could be established and which are tllerefore ta:.i coloricallv cceptable for use in food r,ithin these limits

Carrageenan (E 407/E 408) . . AD1 O-75 rng/?<r b:~"

Pectin (E 44O)(E 4403.) . AD1 not snccifierj .

Sodium an-i pot 2.~r,iurrl polypJ,ilosp:hotes (x 45oc) : Acceptable total dietary phosphorus load f--f

o-7(> m,?/!c~: IJV:

Plicrocrysta‘Jline cellulose (1': 460)/por!derec: cellulose : AD1 not specified

Poly~:lycerol esters of mono- and di-;ylyceride of fat-t;, acids (E 475) . . AD1 O-25 mp;/lc~ b\,.

Sodiu!m ::tcaroyl-2-lact~;l.ate (E 411) ) AD1 O-20 m:a;/'Er:l: bl: sinyl:~ or in Calcium stearoyl-2-lactylate (E 482) ) combi,zation

Partial p~~lv~*lx*ccrol esters c " of poly- condensed fatty acids of castor oil - AD1 O-7.5 m:y+q- br\. .

Sorbitan monopnlmitr:te Sorl\itm monostenrntc Sorbitan tristearatc

;.b!- = bbis]- isci ,-ilt r;7ili r, cstimntt~ a.;~pliic to the sum cf added phos!~l;:~tr: nni fooi phosp:into, Acceptable dnilJ intake levels of nhosphate depend on the amount of calcium in the 'diet. The lcvt-1s :;t3teii 3.pplJ tu diets that are nutritionally adequate !:ith respect to calcium. IIn\ ever, if tile calcium intake !,!ere hi,-h , proportionally hitier amounts of phosphate ~oulcl be acceptable, and the revcrsc relation sould also apply.

Xanthangum : AD1 O-10 mg/kg bw

Extract of Quillaia : AD1 O-5 mg spray dried extract/kg bw

Propane-l,12-diol esters of fatty acids (E 477)’ * : AD1 O-25 mg/kg bw

Ammcilium phosphatides : ADI O-30 mg/kg bw

Fatty acid esters of man+ and diglycerides of fatty acids E 472 d, f) : AD1 not specified E 472 e) : AD1 O-50 mg/kgbw

2, Substances for which a temporary AD1 could be established and which are toxioolo&cally acceptable for use in food within these limits for a period of 3 Nears or 5 years depending on the t,ypes of information required

Amidated pectin (E #Ob) : temporary AD1 e-25 mg/kg bw

Polysorbates (20, 40, 60, 65 and 80) : temporary AD1 0125 mg/kg bw

Polyoxyethylene (40) stearate : temporary AD1 O-25 mg/kg bw

Dioctyl sodium sulphosuccinate : temporary ADI 010.1 mg/kg bw

3. Substances for which an ADI could not be established but which are nevertheless considered temporarily acceptable for use in food

Tragacanth (E 413)(temporary)

Propoane-l,Z-diol esters of fatty acids (E 477)** (temporary)

Polyoxyethylene (8) stearate (temporary)

Oxidatively thermally polymerised soya bean oil interacted with man- and di-glycerides b-w=-34

Lactylated fatty acid esters of glycerol and propane-1,2diol (temporary)

4. Substances for which an AD1 could not be established and which are not toxicologically acceptable for use in food

Karaya gum

Ghatti gum

* with a total content or dimer and trimer of propane-1,2-dial of 0.5sor less ** smith a total content of dimer and trimer of propane-1,2-diol between 0.5$and 4%.

ANNEX1

EldULSIFIERs, STABILIZERS, THICKENERS AND GELLING AGENTS WHICH MAY BE USED IN FOODSmS

EEC No. Designation Conditions of use

E 322 Lecithins

E 339 Sodium orthophosphates

E 340 Potassium orthophosphates

E 34J Calcium orthophosphates

E 400 Alginic acid

E 401 Sodium alginate

E 402 Potassium alginate

E 403 Ammonium alginate

E 404 Calcium alginate

E 405 Propane-1,2-dial alginate

E 406 Agar

E 407 Carrageenan

E 410 Locust bean gum

E 412 Guar gum

E 41.3 Tragacanth

E 414 Acacia or gum arabic

E 420 W sorbitol (ii) sorbitol syrup

E 421 Mannitoi

E 422 Glycerol

E 440 (a) Pectin

E 440 b) Amidated pectin

E 450 (a) (i> disodium dihydrogen diphosphate (ii) triSodium diphosphate

t iii) tetraSodium diphosphate iv) tetraPotassium diphosphate

E 450 04 b-1 pentaSodium triphosphate (ii) pentaPotassium triphosphate

E 450 (c) I

i) sodium polyphosphates ii) potassium polyphosphates

E 460 Microcrystalline cellulose

E 461 Methylcellulose

E 463 Hydroxypropylcellulose

E 464 Hydroxypropylmethylcellulose

E 465 Ethylmethylcellulose

E 466 Carboxylmethylcellulose

E 470 Sodium, potassium and calcium salts of Exclusively in the manufacture of fatty acids 'Dutch' type rusks up to a level

singly or in combination of not more than 1,s of flour used

ITN! No. I Designation Conditions of use

E 471 Mono- and diglycerides of fatty acids

E 472 (a) Acetic acid esters of mor,h and diglycerides of fatty acids

E 472 (b) Lactic acid esters of monc- and diglycerides of fatty acids

E 472 b) Citric acid esters of mono- and diglycerides of fztty acids

E 472 (d) Tartaric'kid esters of nonm'afid diglycerides of fatty acids

E 472 (e> Mon.* and diacetyltartaric acid esters Of mow+ and diglycerides of fatty acids

E 472 (f) MFxed acetic axd tErtaric acid esters of mor,o- and diglycerides of fatty acids

E 473 Sucrose estex of fatty acids 1 These substances may not be ) used in bread unless ) permitted under national

E 474 E 475 E 477 E 481

E @2

E 4-83

Sucroglycerides ) law

Polyglycerol esters of fatty acids

Pro?arx-1,24iol esters of fatty acids

Sodixx stearoyl-2-lactylate ese substances may not be

Calcium stezroyl-2-lactylate

'r -sed in bread unless

iP emitted under national Stearyl tartyate ) law

mix 2

Designation

Karaya gum (synonym: sterculia gum)

Partial polygiycerol esters of polycondensed fatty acids of castor oil

Sorbitan monopalmitate

Sorbitan monostearate

Sorbitan tristearate

Polyoxyefhylene (20) sorbitan

Polyoxyethylene (20) sorbitan

Polyoxyethylene (20) sorbitan

Polyoxyethylene (20) sorbitan

Polyoxyethylene (20) sorbitan

Polyoxyethylene (8) stearate

Polyoxyethylene (40) stearate

monoiaurate (synonym: polysorbate 20)

monopaimitate (synonym: polysor3ate 40)

monostearate (synonym: polysorbate 50)

tristearate (synonym: polysorbate 65)

mono-oleate (synonym: polysorbate 80)

Glyceric esters of fatty acids obtained from soya oil oxidised under heat

Ghatti gum

Xanthan gum

Ektract of quillaia

Lactylated fatty acid esters of glycerol and propylene glycol

Sorbitan monolaurate

Sorbitan mono-oleate

Dioctyl sodium sulphosuccinate

Ammonium phosphatides (synore: emulsifier YN)

ANNEX3 REPORT OF THE SCIENTIFIC COMMITTEE FOR FOOD ON CARlViGEENAN (E 401)

AND FURCELLARAN (E 408) (Opinion expressed January, 1977)

TERMS OF REFERENCES

The Committee was asked to give its opinion on whether carrageenan and furcellaran can be included within a single specification of purity and, if SO, whether substances complying with this specification can be recommended for acceptance on a Community basis beyond June 1979.

CONCLUSIONS

The Committee accepts that on the basis of the current information on source materials, production methods, chemical nature and toxicological information, a single combined specification for carrageenan and furcellaran for food use of high molecular weight is justified.

BACKGROUND

The Directive on the approximation of the laws of Member States relating to emulsifiers, stabilisers, thickeners and gelling agents for use in foodstuffs (74/329/EEC of 18 June 1974) permits the use of carrageenan and furcellaran on a Community basis. However, within 5 years of the notification of the Directive (i.e. by June 1979) the Council, on the basis of a proposal from the Commission, must decide whether to delete, retain or otherwise change the status of furcellaran. (Article 2.2.)

The Commission, in accord with Article 7 of the Directive, is preparing specific criteria of purity for carrageenan and for furcellaran* The producers of carrageenan and furcellaran have stated that formerly these stabilisers were obtained from separate algae sources, but that currently they are both obtained from a wide but similar range of red algae. The producers have therefore suggested that a single combined specification for carrageenan/ furcellaran would now be more appropriate.

SOURCE MATERIALS FOR CARRAGEENAN AND FURCELLARAN

The Committee was informed that the source materials for both carrageenan and furcellaran are red algae of the Order Gigartinaes from the Class Rhodophyceae (1). Carrageenan was formerly obtained principally from algae of the Family Gigartinaceae, in particular, Chondrus crispus. However, the increasing scarcity of such algae has led to the use of red algae from other Families of the same Order - including_Furcellariaceae, Furcellaran was originally obtained solely from the species Furcellaria fastigiata of the Order Furcellariaceae. The Committee was informed that this species is no longer available in sufficient quantities, so that the source material for furcellaran is often a mixture of Furcellaria fastidata with Chondrus crispus and other similar red algae. Thus, there has been a considerable extension of the number of Families of red algae used in the production of carrageenan, one of the Families, Furcellariaceae, being that from which furcellaran is obtained; whilst furcellaran is currently obtained from mixtures of Furcellaria fastigiata and other red algae that arc also used in the production of carrageenan.

PRODUCTION METHODS

The Committee was informed that carrageenan is obtained by extracting the red algae with hot water, filtering the extract and then precipitating the carragecnan with an alcohol (normally propan-2-01 but sometimes ethanol or methanol), Furcellaran can be obtained in similar fashion, thou h it is more usual to precipitate the furcellaran by addition of potassium chloride (1 P . The Committee noted that degraded carrageenan, prepared by the partial hydrolysis of Eucheumaspinosum, ic not used for food purposes but is sold for medical use as an anti-peptic agent (2 .

CHEMICAL NATURE OF GARRAGEENAN-F'URCELLARAN

The product as obtained primarily from Chondrus crispus, potassium,

consists chiefly of the calcium, sodium and magnesium salts of polysaccharide sulphate esters, the dominant hexose

units of which are galactose and 3,6-anhydrogalactose. dry4qeigh-t basis is between 18 and 4% (3)(4).

The sulphate content, as SO4 on a

However, the product obtained primarily from Furcellaria fastigiata, consists chiefly of the potassium salts of polysaccharide sulphate esters, the dominant hexose units again being galactose and 3,&anhydrogalactose. The sulphate content, as SO ranges from 14 to 18 per cent (4). 4

on a dry-weight basis,

The Committee was told that when alcohols are used for precipitation it is difficult to reduce the level of residual solvent to below 1 per cent.

TOXICOLOGICAL IWALUATION AND CRITERIA OF PURITY

The Committee noted that in 190 JECFA published\separate specifications for carrageenan and furcellaran (4), the two substances were considered together for the purposes of toxicological evaluation (5). In 1973, JECFA reviewed the toxicology of the two substances together (2) and in 1974 decided to put forward tentatively a single combined specification (6).

The Committee accepts that on the basis of the current information on source materials, production methods, chemical nature and toxicological information, a single combined specification for carrageenan and furcellaran is justified stating that the minimum viscosity of1.5 per cent solution should not be less than 5 centipoises at 75°C.

The Committee gave attention to solvent residues and to the molecular weight restrictions.

The Committee recommends that the levels and kinds of residual solvent in the final product should not exceed 1 per cent for methanol, ethanol or propan-2-01 (isoprooanol) singly or in combination. The Committee considers that, if practicable the use of methanol should be avoided and the product should only be obtained using ethanol or propan-2-01.

The Committee noted the evidence summarised by JECFA (2) that de raded carrageenan has an ulcerogenic effect in some animal species (rat, guinea pig, rabbit but not others (mouse, -+-- hamster , gerbil, ferret, pig, squirrel or monkey). On the other hand there is no evidence that patients given degraded carrageenan for the treatment of peptic ulceration and ulcerative colitis have suffered ill effects. Since then Engster and Abr‘aham have published their work on the caecal response to different molecular weights and types of carrageenan in the female guinea pig (7). Kappa (K) and Lambda (3 fractions were obtained by treatment of Chondrus crispus extracts with alkali and precipitation by alcohol. Iota (i) fractions were obtained from Eucheuma spinosum extracts after acid hydrolysis. Results are summarised briefly in the following table:

Fraction

K K

i A A i i i i i

11.95 1.451 0.117

314.000 51.500

8.500

10.250 275.000 2.243 74.800 0.503 20.800

7.51 145.000 5.34 107.000 4.19 88.000 1.62 39.000 0.685 21,CCC

Number average molecular weight

(Mn)

Response to l$ solution in drinking water (2 weeks)

negative negative negative

negative negative negative

negative + + -t+ +-t-

Response to 2$ level fed in diet (10 weeks)

n-t nt nt

nt. nt nt

negative ner;ative negative negative ne(:ative

Fraction . r Intrinsic Number average Response to l$ viscosity molecular weight solution in (dl/d b-d drinking water

(2 weeks)

0.285 I

8.700 I

+

0.113 ca 5,000 negative

Code:

+ epithelial thinning, slight erosion, cellular infiltration and

+ f as above , plus ulceration of the caecal mucosa.

n-t not tested.

Response to 2% level fed in diet (10 weeks)

t negative

nt I

crypt abscesses in caecum*

Pittman, Golberg and Coulston (8) give a variety of Iota, Kappa and Lambda carrageenans to guinea pigs, monkeys and rats, either in drinking water or by gavage or in the diet. Substantial amounts of carrageenan were found in the livers of guinea pigs and rats given low molecular weight i, K orA carrageenans (below 40.000 Mn), Intermediate amounts were found in the livers of animals given carrageenans ranging in number average molecular weights (Mn) between 40.000 and 150,000. Degradation occurred on or after passage through tl intestinal tract since the Mn values of carrageenans from the livers of guinea pigs tended to be about 10.000, Excretion of carrageenans in the urine was limited to values of Mn of probably 10.000 or less. The authors calculated that i-carrageenans containing only molecules of Mn above 50cOO0 - 85,000 Mn would not be absorbed and found in the liver.

9;he Committee was of the opinion that the evidence conceaning possible adverse effects of degraded carrae;eenan in the human diet was inconclusive. However, as a matter Of prudence the level of degraded carrageenan in carrageenan for food use should be kept to a minimum. There is no reliable analytical method for detectin& small amounts of degraded carrageenan in food grade carrageenan, But the Committee was informed that in practice this does not present a problem since, for food use, undegraded carrageenan is less expensive and superior from a technological view point. Degraded carrageenan is made by a separate process.

263

L

%Since submitting this report the Committee was . in recent studies on degraded carrageenan (9),

informed about the adverse findings reported which reinforce its opinion that food grade

carrageenan should contain 3s low a level as po ssible of de,Traded materinl. In order to align this earlier report with the formal presentation in its present Report on Emulsifiers, Stabilizers, Thickeners, anId Celling Agents, the Committee wishes to record that it does not object to the endorsement of the AD1 of O-75 mg/iig bw established by JECFA.

REFERENCES

1. Industrial Gums, Roy, L. Whistler (Editor), Second Edition (P. 150), Academic Press, New York and London, 1973.

2. Toxicological Evaluation of Some Food Additives, FA0 Nutrition Meetings Report Series No. 53A, WHO Food Additives Series 1974, no, 5, FAO/WRO, Rome/Geneva, 1974.

3. Food Chemicals Codex, Second Edition 1972 and National Academy of S ciences , Washington D.C.

First Supplement, 1974.

4. Specifications for the Identity and Purity of Some Food Colours, mulsifiers, Stabilisers, Anti-caking Agents and Certain Other Substances. FA0 Nutrition Meetings Report Series No. 46B, WJJO Food Add/70.37. FAO/WO Rome/Geneva, 1970.

5. Toxicological Evaluation of Some Food Colours, Rnulsifiers, Stabilizers, Antioakirq: Agents and Certain other Substances, FA0 Nutrition Meeting Report Series No, 46~, WHO/Food Add/70.36. FAO/WO, Rome/Geneva, 190.

6. Specifications for Identity and Purity of Some Food Additives, FA0 Nutrition Meetings WHO/Food Add/7

Report Series No, 54B,

FAO/WO, Rome/Geneva, 1975.

7. Cecal Response to Different Molecular Weights and Types of Carrsgeenan in the Guinea Pig. Engster, M. and Abraham, R., Toxicology and Applied Pharmacology, 38, 265-282, 1976.

8. Carrageenan: The Effects of Molecular Weight and Polymer Type on its Uptake, Excretion and Degradation in Animals. Pittman K.A., Golberg L., and Coulston, F. Food and Cosmetics Toxicology, 14, 85-93, 1.976.

9. Induction by Degraded Carrageenan of colorectal tumours in rats. Wakabayashi K., Inagaki T., Fujimoto Y., and Fukuda Y. Cancer letters, 4, 171-176, 1978.

17

REPORT OF THE SCIENTIFIC COMMITTEE FOR FOOD ON GUAR GUM (E 412)

(Opinion expressed January 1977)

TERMS OF REFERENCE

The Committee was asked to express its opinion on the implications of a recent report on research on guar gum (1) in relation to proposed specifications for this substance and its continued inclusion on the Community list of acceptable emulsifiers, stabilisers, thickeners and gelling agents.

CONCLUSIONS

The Committee concluded on toxicological grounds that the protein content of guar gum for use in human food should be as low as possible. There was some evidence that a level of 5 per cent protein in guar gum should be technologically feasible, but, meanwhile, the Committee would not object to the continued inclusion of guar gum (milled endosperm of guar seed on the Community list of acceptable emulsifiers, stabilisers, thickeners and gelling agents provided that the protein level of the gum does not exceed 7 per cent.' This opinion on acceptability for use in food relates solely to use at the levels required for emulsifying, stabilising or thickening purposes, normally not exceeding 2 per cent. Further consideration would need to be given to the acceptability of guar gum for dietary products (e.g. as a bulking aid in low energy preparations) when levels of use could be in excess of 2 per cent.

BACKGROUND

The Council Directive on the approximation of the laws of Member States relating to emulsifiers, stabilisers, thickeners and gelling agents for use in foodstuffs (74/329/EEC of 18 June 1974)pe rmits the use of gear gum on a Community basis. Article 7 of the Directive requires that the Council on a proposal from the Commission, shall lay down specific criteria of purity. During discussions on these criteria of purity with experts from the Member States the Commission's attention was drawn to a report b Feldheim and Stamm on animal feeding trials with guar seeds and guar seed fractions (1 .

The Commission therefore requested the Committee's opinion on the implications of this report as regards both the proposed specification for guar gum and the continued acceptability of ,guar gum for inclusion in the Directive.

PRODUCTION TECHNOLOGY, TERMINOLOGY AND USAGE

The Committee were given details of the method of production of and terminology for the various guar seed products (2)( 3). The guar seeds are crushed and the germ, endosperm and husks separated mechanically.. The per-m is milled to produce raw guar meal. heat treated prior to use as a protein source in animal feed. The endosperm give the product known as par gum and the husks are discarded.

This is usually is milled to

Guar meal has a protein content of about 45-50 per cent. Pure guar endosperm, separated by hand, has a protein content of about 4-5 per cent. However, commercial guar endosperm (guar gum) contains small residual amounts of germ and husk which it is claimed cannot be - separated economically without substantial loss of endosperrn. The Committee was informed that the maximum protein content of 7 per cent for guar gum suggested as practicable by the trade would imply that its term content was no higher than 6 per cent. The Committee was provided with the following table showing the composition of guar seeds and their utilisable products (2):

d. calculated on the basis of total nitrogen determination and using the factor of 6.25 to convert total nitrogen to protein.

. Product Protein Content Galact omannan '

w> Content ($) Use

Guar seed

(cyamopsis tetra gono- 28-34 30-35 Source material

lobus L).

Guar meal 45-w 6-10 Animal feed

bwd Guar gum

(endosperm)

- technical grade 65 paper, textiles

mining

thickener and stabiliser

As a thickener and stabiliser, use levels in food are generally no more than about 2 per cent.

TOXICOLOGICAL INFORMATION

In 1975 the FAO/WHO Joint mpert Committee on Food Additives (JEZFA) confirmed its evaluation of "AD1 not specified" for guar gum (5)+Feldheim and Stsmm's report (1) appeared in 1976 and was not therefore considered by JECFA. Feldheim and Stamm summarised earlier feeding trials on cattle, poultry and rats with guar seeds or their protein-rich or carbohydraio-rich fractions. The protein-rich fractions caused toxic effects which were diminished if heated fractions were fed. Carbohydrate-rich fractions depressed growth. According to the authors this was probably due to poor utilisation of galactomannans (the main carbohydrate fraction of guar) by the animals or to a decrease in fodder consumption due to expansion of the fodder in the gut. Feldheim and Stamm cited other studies in which

rotein caused swelling and inflammation of the intestines when fedtorats. E,i'$:: fltsf---- the protein-rich fraction) is known to contain a trypsin inhibitor (6,7) as do many o= plant seeds (e.g. soya beans). The Committee was informed that preliminary tesisshowed the trypsin inhibitor activity of guar meal to be about 20 per cent of the activity found in soya protein and that no trypsin inhibitor activity could be detected in guar gums with 4 to 10 per cent protein content (3).

f In order to align this earlier report with the formal presentation of its present Report on Emulsifiers, Stabilizers, Thickeners, and Gelling Agents, the Committee wishes to record that it does not object to the endorsement of the AD1 "not specified" established by JECFA.

19

REFERENCES

1, Guar II. Feeding Trials with Animals, Feldheim., W., and Stamm, I. 2 Lebensm. Unters - , 11-1'8 (1976).

2. Professor Dr. R. Franck (personal communication) Max von Pettenkofer Institute, Berlin 33. Member of Scientific Committee for Food.

3. Unpublished information supplied to the Commission by Institute European des Industries de la Gomme de guar et caroube.

4. Gum Technology in the Food Industry, Martin Glicksman, Academic Press, New York and London, 1969.

5. Toxicological evaluation of some food colours, thickening agents, and certain other substances, FA0 Nutrition Meetings Report Series NO, 55s. WHO Food Additives Series No. 8. FAO/K30, Rome/Geneva 1975.

6. Couch J.R., Bakshi I,BT., Prescott J.14., and Greger C,R, Federation Proceedings 24, 687, 1965.

7. Berichte, 1973. Deutsche Forschungsanstalt fiir Lebensmittelchemie, Mcnchen.

20

REPORT OF THE SCIENTIFIC COMMITTEE FOR FOOD ON ESTERS OF MONO- ANNEX>

AND DI-GLYCERIDES OF FOOD FATTY ACIDS (E 472) (Opinion expressed January 1977)

TERMS OF REFERENCE

To give an opinion on the adequacy of the current designation for E 472 at Annex I of the Council Directive on the approximation of the laws of Member States relating to emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs (74/329/EEC of 18 June 1974), and whether the mixed acetic/tartaric esters are acceptable for use in food from the point of view of the health of the consumer.

CONCLUSIONS

1. The Directive should be reworded so as to permit only specific mono- and di-glycerides whether produced from one or more than one of the specified organic acids.

2. The Committee is prepared to accept the specific inclusion of the mixed acetic/tartaric acid esters on the Community list of emulsifiers (etc.).

BACKGROUND

The Directive permits the use in foodstuffs, on a Community basis, of certain esters of mono- and di-glycerides of food fatty acids. These are :

(a) Acetic acid esters;

(b) Lactic acid esters;

(c) Citric acid esters;

(d) Tartaric acid esters;

(e) Mono and diacetyltartaric acid esters.

This wording has been interpreted in different ways in various Member States and this has led to different applications of the Directive in national legislation.

One interpretation is tha.t these mono- and di-glycerides may only be esterified with one of the five listed acids at a time.

A second interpretation is that mono- and di-glycerdies may be esterified with one or any combination of the five acids listed above.

The first interpretation is complicated by the fact that lactate, citrate, tartrate and diacetyltartrate all have more than one functional group which can take part in ester linkages - even though only one of the five acids is used for esterification. The same complication arises for the second interpretation but, in this case, the number of possible end-products can be even greater when more than one of the five acids is used for esterification.

OPINION ON THE CURRENT DESIGNATION FOR E 472

The Committee rejects the second interpretation and recommends that the Directive be re-worded so as to permit only specific man+ and di-gl*yceride esters hrhether produced from one or more than one of the listed acids. of the acids (a) - (e)

This means that esters produced from one above are considered acceptable.

Other products made from more than one of the listed acide will have to be considered individually on their merits. acetic/tartaric acid esters.

The Committee has only been asked to consider the mixed

f In order to align this earlier report with the formal presentation of its present Report . on Emulsifiers, Stabilizers, Thickeners and Gelling Agents, the Committee wishes to record &at it does not objet to the endorsement of the ADIs established by JECFA.

21

OPINION ON THE MIXED ACETIC/TARTARIC ACID ESTERS

The Committee was provided with the results of two long-term feeding studies using commercial formulations based on the mixed acetic/tartaric esters, and with the composition of these formulations. Mosinger (1) administered one formulation for 24 months to 15 male and 15 female Wistar rats at 5 g/kg body weight per day. The author reported normal growth rates, no carcinogenic effect and no effects on reproduction and progeny over 2 generations. Lang, Xieckebush and Griem (2) investigated another formulation reporting the LD for male mice as greater than 20 g per kg body weight. Groups of 2C male and 20 female r 2? s were fed the substance in doses of 100 mg/kg body weight and 400 mg/kg body weight over a period of 26 months. The authors reported no adverse effects in the rats with regard to growth, food consumption, food efficiency, state of health, reproduction (two matings), survival and gross and hi&o-pathology of the organs*

The toxicological data submitted, which relates to the same esters in two different formulations,indicates that from the point of view of safety in use these esters are comparable to substances already permitted by the Directive.

The Committee is therefore prepared to accept the specific inclusion of the mixed acetic/ tartaric acid esters on the Community*list of emulsifiers, stabilisers, thickeners and gelling agents for use in human food.

REFERENCES

1. Professor Me Mosinger Effects of prolonged oral administration of T 500 Puratos (unpublished report 1965). Institut de Medecine L&gale et Institut d'Hygi8ne Industrielle et de Mgdecine du Travail, Marseille 7

2. Lang K., Kieckebush W. and Griem W. Lowterm feeding tests with baking aid T 500 S (unpublished report 1970).

Physiologish-Chemisches Institut der Universitat, Mainz.

3. Toxicological evaluation of some food colours, thickening agents, and certain other substances

FA0 Nutrition Meetings Report Series No. 558 WHO Food Additive6 Series No. 8 FA/OWHO Rome/Geneva 1975

*In order to align this earlier report with the formal presentation of its present Report on Rnulsifiers, Stabilizers, Thickeners and Celling Agents, the Committee wishes to record that it does not object to the endorsement of the AD1 established by JECFA (3).

REPORT OF TRE SCIENTIFIC COMMITTEE FOR FOOD ON PECTINS (E 440) AWEX 6

(Opinion expressed February 1977)

to express an opinion on whether smidated pectin point of view of specifications and toxicology.

could be classified

CONCLUSIONS

1.

2.

3.

The Committee agreed that pectin and amidated pectin should be specified separately on the basis of present technological and toxicological evidence.

The Committee was prepared to accept a temporary ADI of O-25 mg/kg~body weight for smidated pectin provided that the results of further toxicological studies be received by 1982. The Committee thought, that for it to be fully informed, these studies should include adequate reproduction, embryotoxicity and teratology studies in rats and an adequatelong-term study in a rodent species preferably the rat.

The Committee endorsed the AD1 "not specified" established by JECFA for non-amidated pectins.

BACKGROUND

The Council Directive on the approximation of the laws of Member States relating to emulsifers, stabilisers, 1.8 June 1974)

thickeners and gelling agents for use in foodstuffs (7@29/EEC of authorises the use of "E 4-40 Pectins" (Annex I). Article 7 of the Directive

requires that the Council,acting unanimously on a proposal from the Commission, shall lay down specific criteria of purity for "Pectins". During discussions on these specifications, the Commission found that experts of certain Member States were reluctant smidated pectin as falling within the designation "E 4.40 Pectins", partly reasons and partly on the grounds that amidated pectin cannot be regarded pectin.

to accept for toxicological as a "natural"

TECHNOLOGICAL INFORMATION (1)(2)( 3)

Pectins are complex acidic polysaccharides which occur in varying amounts in plant cell walls and which have the ability to form gels with sugars plus acids. They are obtained by the extraction of plant materials (usually citrus fruits, apple pomace or sugar beet) with hot water or dilute acids and are concentrated by evaporation and sold as such,, or dried, or recovered from extracts by precipitation with alcohol or salts of polyvalent metals, usually aluminium and then dried.

Pectins have for many years been used to improve the consistency of jellies, jams and marmalades prepared from fruits containing insufficient endogenous levels of pectins.

Pectins consist chiefly of the partial methyl esters of polygalacturonic acid and their calcium , potassium, sodium and ammonium salts. Normally pectins contain 7 to 12 per cent methoxyl content by weight, implying that some 45 to 75 per cent of the carboxyl groups in the pectin are esterified. For gel formation with such pectins, sugar must be present in amounts of 50 per cent by weight or more and the pH must be below 3.5.

A major development has been the production of low-methoxyl pectins by partially de-methyl- sting normal pectins with acid, alkali or enzyme treatments. Methoxyl content6 range from 2 to 7 per cent by weight. Low-methoxyl pectins require little or no sugar for gel formation and satisfactory gels can be prepared within a wide range of pH e.g. 2.5 to 6.5. They are however sensitive to high levels of calcium ions.

For amidated pectin partial de-methylation is achieved by the use of ammonia in alcoholic solution. Amidated pectin contains about 5 per cent of amide groups, which implies that about 20 per cent of the carboxyl groups have been amidated. Amidated pectins do not

howeverprecipi tateinthe presence of high levels of calcium and can t the production of milk-based products.

herefore be used in

The Committee was informed that about 20 per cent of the pectin used commercially is of the low-methoxyl type (either amidated or non-amidated). The level of use is said to be about 0.3% for jams and jellies and up to 1% for other uses such as milk gels, fruit gels, ice cream, yogourt. The Committee was also informed that about 85-9s of all pectin is used in the production of jellies and jams.

TOXICOLOGICAL INF'ORMATION

The FAO/NHO Joint Expert Committee on Food Additives (JECFA) evaluated pectin in 1973 (4) and amidated pectin in 1975 (5). Though the evaluations differ - a temporary AD1 of'0025 mg/kg body weight for smidated pectin and an AD1 "not specified" (AD1 "not limited" in 1973)* for no-idated pectins - JECFA have included both types within a single specification entitled "Pectin" . (6)

In addition to the JECFA review, the Committee was provided with copies of the unpublished reports of Til, Seinen and de Groot (7), of Palmer, Jones and Abul Haj (8) and of Mosinger (9). The Committee was also provided with preliminary reports of long-term, teratology and reproduction studies on rats with pectin and amidated pectin now in progress in France-(10).

The Committee noted that in the studies by Til, Seinen and de Groot there was slight evidence that amidated pectin might be more toxic to rats than ordinary pectins, in giving a slight degree of hyperkeratosis of the fore-stomach and increased leucocyte counts in femals at dietary levels above 5 per cent, and more pronounced increases in caecum weights (7). Palmer, Jones and Abul Haj found no significant differences between rats fed pectin or amidated pectin for 2 years at dietaSy levels of 10 per cent (8). Mosinger administered amidated pectin in single doses of 100 mg/kg body weight daily to rats (approximately 0.2$ in diet). There appeared to be no adverse effects at this low dietary level in comparison with available data from historical controls experiment (9).

- no contemporary controls were used in the The results of these experiments were therefore difficult to interpret in a

safety evaluation. The Committee was informed that no adverse effects had been noted in the study now in progress (10). The Committee'agreed that neither of the completed lowterm studies was adequate either in terms of number of animals used, levels fed or design of the experiments. The Committee was prepared to accept a temporary AD1 of O-25 rnc/ kg body weight for amidated pectin provided that the results of further toxicological studies be received by 1982. The Committee thought, that for it to be fully informed, these studies should include adequate reproduction, embryotoxicity and teratology studies in rats and an adequate lowterm study in a rodent species preferably the rat. The Committee endorsed the AD1 "not specified" established by JECFA for non-arnidated pectins.

A This term was previously used by the JECPA Report of 1974.

1. n Producers International Association of Pecti Evidence submi .tted to Commission.

2. Gum Technology in the Food Industry, Martin Clicksman, Academic Press, New York and London, 1969.

3. Industrial Gums, Editor, ReLe Whistler, Academic Press, New York and London, 19'73.

4. Toxicological Evaluation of Some Food Additives, FA0 Nutrition Meetings Report Series No, 53A. WHO Food Additives Series No. 5, 1974. FAO/wHO, Rome/Geneva, 1974.

5. Toxicological evaluation of some food colours, thickening agents, and certain other substancesa FA0 Nutrition Meetings Report Series No, 5511, WHO Food Additives Series No, 8, 1975, FAO/HHO, Rome/Geneva, 1975.

6. Specifications for the identity and purity of some food colours, flavour enhancers, thickening agents and certain other food additives, FA0 Nutrition Meetings Report Series NOe 543, WHO Food Additives Series No, 7, 1976, FAO/WHO, Rome/Geneva, 196,

7.

8.

9.

10.

Sub--chronic (9 day) toxicity study with two samples of pectin in rats, Til, H.Pt, Seinen W., and de Groot AaPe, c Unpublished Report No. R. 3843, Centraal Institut voor Voedingsonderzock TNO, 1972,

Two Year Pectin Feeding Study on Rats, Palmer G.H*, Jones T.R., and Abul Hajs S.K,, Sunkist Growers Inc., 1974.

Effects of the prolonged oral admiristra-tion of amidated pectin to rats, Professor M. Mosinger, Centre d'tiplorations et de Recherches Mkdicales, Marseille, 1975.

Progress Report on long-term, teratology and reproduction studies on rats, Professor M. Kosinger, Centre d'Explorations et de Recherches Mt5dicales. Marseille. November 1974.

RE3?EXZNCES

wacanth (E 413) Descrij$ion m-m --

Tragacanth is considered to contain two primary constituents, bassorin and tragacanthin, The lesser component, tragacanthin, is water soluble and contains 3 molecules of a uranic acid and 1 molecule of arabinose, with a sideachain of 2 molecules of arabinose. The larger component, bassorin, which swells but is insoluble in water, has been shown to contain polymethoxylated acids that yield tragacanthin upon demethoxylation.

A description and criteria of purity are specified in the EEC Directive 78/663/EEC,

Tragacanth has found application as a stabilizer in 10~ pH salad dressings, as a thickener and binder in confectionery, and as a stabilizer in ice-cream and essential oil emulsions.

Toxicolo@cal Evaluation -em- -m"a..--- 0-m

The Committee examined the available data which included preliminary metabolic studies, short term studies in both the mouse and chicken, mutagenicity studies (host mediated assay, cytogenetic studies and dominant lethal studies), teratogenicity studies in rats, mice, hamsters and rabbits and studies on allergic response. The mutagenicity and teratogenicity studies were all negative and showed no adverse findings. absence of conventional 90 day and/or long term studies it

Nevertheless, because of the was not possible to establish

an ADI. For that purpose a long term study is required.

Bachmann and Zbinden (1~r78) carried out a special study to elucidate the mechanism of action of tragacanth and a few other thickening agents (eeg, gum arabic) on cardiac function. The authors studied dose levels ranging from 23 to 80 mg/kg body PIeight daily for a period of 4 weeks on the biochemical functions of heart and liver mitochondria. The uncoupling effect noted soon after administration disappeared during the second half of the experiment. In the liver this uncoupling effect was moderate and progressive. The relevance of these findings to human health should be studied more extensively before these findings can be used in any evaluation of safety,

The Committee agreed to accept Tragacanth on a temporary basis for 5 years and expects to receive the data requested within 4 years,

References a------ 1.

2. 3.

49 5. 6. 7. 8.

9. 10. 11.

Brown, E.B., and Crepen, S.B., (1947) J. Allerm, g(3), p 2l+5,

Fcd.Reg., (1974), U.S, FedqRwe, 39(185), 28.9.144, 34207. Frchberg H., Oettel H., and Zeller il., (1969)) Arch.Toxicol,, p 268-295. Fujirnoto J.M., (ly65), Tox.Appl.Pharmacol., 1, pe 287-290. Galbraith W., Mayhew E.,and Roe E.M.F., (1962) Brit.J.Cancer, l&(l), p. 163-169, Celfand H,H., (1943), J.Allera, 14, pe x>3-219. Celfand H.H.,(1949), J. Allerm, 20(5), pa 311-321. - Riccardi B.A., and Fahrenbach K.J., (1965), Fed.Proc., z, p. 263. Vohra P.,and Krat::er F.H., (1964), km.ltrN Sci., Q(5), ~0116&1170-

Zawehry M.R., Fattah A.A., and Bahnasn~:y ti-A.,(1963), Indian Je Der-m., 8, PO 69

Bachmann E., and Zbinden C,, (ly78), Arch.Toxikol., Suppl, 1, pe 163-18'7

26

Sodium and Potassium PoQYhosphates (E -450~)

Description -L-L-L

A description and criteria of purity are specified in the EEC Directive 78/663/E~C.

Sodium and potassium polyphosphates are used at levels of 0.2T-0.'j$ in various meat poultry and fish products. They are claimed to contribute to colour, tenderness, juiciness and flavour, and to decrease cooking shrinkage. In sausages and similar meat products their use is claimed to increase the stability of the fat emulsion and to reduce the separation of fat during cooking. It is also claimed that polyphosphates afford some measure of microbial protection, particularly against Gram positive bacteria.

Polyphosphates are used also in the processing of milk products, particularly in the manufacture of processed cheese. At a level of about 3% in cheese processing they aid pH control, sequester calcium ions and act as emulsifiers. They are also used at levels from 0,02$-l% for milk gelling preparations (such as instant puddings), for the stabilisation of HTST sterlized milk concentrate and texture stabilization of alginate-based ice-creams. Sodium polyphosphate also finds application in coffee whiteners to stabilize the milk proteins when the whitener is added to hot liquids.

They are also used at varying levels in fruit and vegetable processing, where the act predominantly as sequestrants of trace amounts of heavy metals (e.g. iron, copper , to enhance colour stability and decrease oxidative spoilage.

Toxicolo@cal Evaluation mm-- ---cm.---

The Cormnittee had no objection to their present use, as long as they complied I-,rith the existing specification. It endorsed the acceptable total dietary phosphorus load, established by JECFA, of O-70 mg/kg bw. This estimate applies to the sum of added phosphate and food phosphate. Acceptable daily intake levels of phosphate depend on the amount of calcium in the diet. The levels stated apply to diets that are nutritionally adequate with respect to calcium, However, if the calcium intake were hivh b , proportionately higher intakes of phosphate would be acceptable, and the reverse relation would also apply.

References -O.-w---

1.

2.

Toxicological Eionographs Arising from the Fourteenth Meeting of the Joint FAO/WHO Expert Committee on Food Additives, WHO/Food Add/70.39, FA0 Nutrition Meetings Rep.Ser., No. 48A, (W'o)~ P- 66,

Ivey F.J., and Shaver K., (1977), gric.Food Chem,, a(2), p. 128-130

Wcrocrystalline Cellulose (E 460) - Powdered Cellulose

Description c-c --

A definition and criteria of purity are specified in the EEC Directive 78/663/EEC for microcrystalline Cellulose.

Technolo@cal _ApElication L-L- -- c--v

Microcrystalline/pob:dcred ccllulosc is claimc:1 tc lie pnrticul3rly effective in affordily: stability and melting resistance to low solid prod-acts. Typical use levels in food Fre 5% in salad dressings, 1.s in whipped topping, 1.3: in synthetic cream, and 0.5$-1.5$ in ice-cream.

2:

,To~i~o~o@cal Evaluation m-w- ---w

The Committee agreed to endorse the ADI "not specified" established by JECFA but wished to be informed of any further work elucidating the problem of persorption, If any new findings became available the Committee would r-assess the scientific evidence. The Committee concluded that powdered cellulose could be'considered toxicologically similar to , microcrystalline cellulose and similarly acceptable for use in food, provided the specifications of these substances were comparable in all major respects*

1.

2.

3.

4.

5.

5,

79

Battista O.Ao, and Smith P.A., (l962), Ind andzng.Chem;, 2, pa 20

Toxicological Monographs Arising from the Fifteenth Report of the Joint FAO/WHO Expert Committee on Food Additives; FA0 Nutrition Meetings Report Series, No. 50A, WHO Food Additives Series No I~, (1972), p. 83

Tusing T,W., Paynter O.Eo, and Battista O.A., (1964), Agric.Fd.Chem., l2, pe 284e

Hazleton Laboratories IncI, Unpublished Report, (1963).

Hazleton Laboratories IncIl Unpublished Report, (1964).

Hazleton Laboratories Inc,, UnpuXished Report, (1962).

Pahlke C,, and Friedrich R., (1974), NaturtzTiss.t 6l(2), p. 35

Carboqmetheellulose (Es)

Description UIILLIIe.‘.

A description and criteria of purity are specified in the EEC Directive 78/663/EEC,.

zezhzo_l;o@cal Application w-L1 o..---

Car't,ox~~e-thylcellulose is u.>~- c-311 as a sta'bilizer for frozen confectionery (ecg* ice-cream, sherbets, etc,) to prevent ice crystal growth. It preverrts syneresis in icings, meringues, jellies, pie fillings and in puddings. In cakes and other baked goods it finds application as a moisture retainer*

Toxicolo&cal Evaluation cm-- --w-w c-m

Tne Committee was of the opinion, that there were no toxicological reasons for specifying a limit to the molecular weight. The Committee endorsed the AD1 established by JECFA.

References -I----

1, Toxicological Evaluation of some Food Additive s,includiq Anticaking Agents, Antimicrobials, Antioxidants, Emulsifiers and Thickeniw Agents, %X0 Food Additives Series, (1974), No. 5,.

Polyglycerol Ester:; of Fatty Acids (E Jb, L- J

Description w-w CI

A description and criteria 01' purity zrc sp~crficd jr-1 the! Directive 78/663/EEC.

Technological Application w-w ----M--1--

Polyglycerol esters of fatty acids are used at a level of 0,5-3$ in fats, oils, margarine and fat emulsions. They are claimed to be satisfactory for gelling oils in order to reduce the quantity of hard fats in a margarine blend, In addition they are claimed to reduce spattering during frying and the tendency for margarine to weep or show exudation on storage. This emulsifier is very important in bakery products, particularly for high ratio cake recipes where it also facilitates aeration.

Polyglycerol esters of fatty acids are also used in chocolate and chocolate coatings at a level of up to 1%. They afford improved fat plasticity, an emulsion stabilizing effect, and an improvement in the formation of mousses. Anti-fat bloom properties are also claim&

Toxicological --cIc--- Evaluation )ILII1I-

An apparent discrepancy exists between the FAO/WHO JEXFA specification and that included in the EEC Directive. Accordi% to the FAO/WHO specification "no polyglycerols higher than hexaglycerols should be present" whereas the EEC specification permits the presence of not more than 10% polyglycerols equal to or higher than heptaglycerol. The possible difference in camposition between the product studied toxicologically and evaluated by JECFA and the material characterised by the EEC criteria prompted the Committee to request further details. The Committee has now been informed that the emulsifier has been manufactured continuously by the same process and that progress in analytical techniques was the sole reason for the difference. On the basis of this evidencs the Committee concluded that the toxicity data was obtained on material described by the EEC specification, The Committee considered the toxicological data to be acceptable and endorsed the AD1 of O-25 mg/kg bw established by JECFA.

References -m-c--

1.

2.

3.

4*

5.

Toxicological Monographs arising from the Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives; FA0 Nutrition Meetings Report Series No 53A, IhO Food Additives Series, No, 3, (1974), p. 241.,--‘-

~-.--.-~

Unilever Research Laboratory, Unpublished Report, (1966).

BabayanVcK., Kaunitz H., and Slanots C.A., (1964), J.Amer.Oil Chem.Soc., $L, p. 434.

Ostertag H., and Wurziger Ja, (196'j), Rrzneimittel-Forsch,, 1;2, p. 869.

Seventeenth Report of the Joint FAO/hXO Expert Committee on Food Additives, FA0 Nutrition Meetings Report Series No. 53, WHO TeshrG.cai Report Series No.=, (1974), p.20.

Propane-1,2-dial Esters of Fatty Acids CE 471)

Description N-w --

Propane-1,2-dial Esters of Fatty Acids are used in powdered and liquid cake shortenings to improve texture and volume in baked goods and to improve shippability an3 stability in powdered desserts and whipped toppings. In icings they improve aeration and stability.

Toxicolo@cal Evaluation w-w- NW W-M V-B

The Committee noted that the evaluation carried out on the substance by JECFA Was based primarily on the biochemical evidence that the compound is hydrolysed into fatty acids and propylene glycol. The JECF'A assessment appears to have heen made on a product Khich did not contain appreciable quantities of dimcr and trimer. The Committee w?s provided \:ith a summary of data from a thirteen week rat feeding study on propylene glycol monostearate said to be produced by the propylene oxide route, Kith the implication that at least @ dimer and trimer would be present. These data lacked information on histopathology. The Committee was unable to decide on the basis of this information, whether indeed dimer and trimer were present in appreciable quantities.

The Committee decided:

1. To endorse the AD1 established by JECFA for the compound containing less than 0,s dimer and trimer and to accept temporarily for use in food, without establishing an ADI, the compound containing more than 0.5% to 4% dimer and trimer.

2, A metabolic study on the fate of propylene glycol dimer and trimer is required.

3. If full reevaluation of the rat study sho:ss it to be unsatisfactory another 90 day study would be required on the product containing more than 0,s dimer and trimer. This, together with the metabolic study should be available for assessment within two years.

References --..I MM

1. Toxicological Monographs arising from the Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives, FA0 Nutrition Meeting Report Series No. 53A, WHO Food Additives Series, No. 5, (1974), p. 505.

Sodium Stearoyl-2-lactylate (E 481) Description M-M MM

A description and criteria of purity are specified in the Directive 78/663/~~~.

Technolo@cal Application M-M- MM- M-II

Sodium stearoyl-2-lactylate hasthe ability to bond with both proteins and starches and, unlike calcium stearoyl-2-lactylate, it is an effective emulsifier in water-oil systems. This substance therefore finds application as a dough conditioner/emulsifier in high-fat, yeast-leavened baked goods. Its use at a level of about 0,s (based on flour weight) in baked goods, is considered to improve volume and keeping quality and to give a finer, more uniform crumb@ It is also, at a level of about 0.s used as an aerating agent in both diary and non-dairy whipped toppings and desserts. It has been used at a level of 0.8 in non-dairy coffee creamers where it functions both as a surfactant and ccmplexing agent.

Toxicolo@cal Evaluation MM-M -cc-----

The Committee endorsed the AD1 established by JECFA.

References M-L-M-M

1. Toxicological Monographs arising from the Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives, FA0 Nutrition Meeting Report Series, No. 53A, WHO Food Additives Series No. 2, (19741 p. 505

2. Hodge H.C., (1953), Unpublished Report dated 2 April 1953 submitted by C.J. Patterson Co.

3. Hedge H-C., (1955), Unpublished Report dated 17 June 1955 submitted by C.J. Patterson CO,

Calcium Stearoyl-2-lactylate (E 482)

Description M-M NM

A description and criteria of purity are specified in the EXC Directive 78/663/EXC.

T-ezhnolo@cal Applications MM MI- -----

Calcium stearoyl-2-lactylate is used at a level of 0,s (based on flour weight) in yeast- leavened bakery products such as bread, buns, cakes, etc., and also in their respective ready-t-use mixes. As a component of the dough calcium stearoyl-2-lactylate acts in combination with gluten to give the dough greater tolerance to virtually all processing

variables, and thus contributes to the production of baked products of more uniform quality. The use of this substance is considered to impart many desirable characteristics to baked goods, such as more uniform overall quality, an improved volume, a finer, more uniform grain and texture, a more tender crust, and improved keeping properties. Calcium stearoyl-2-lactylate may also be used at a level of 0,s as an egg-white whipping aid.

Toxicological Evaluation -----L-III L-

The Committee endorsed the AD1 established by JECFA,

1. Toxicological Monographs arising from the Seventeenth Report of the Joint FAO/KHO Expert Ccmmittee on Food Additives; FA0 Nutrition Meetings Report Series, No, 53A, WHO Food Additives Series, NO. 5, (1974), P. 505.

2. Hodge H.C. ,(1953), Unpublished Report dated 18 July 1953 submitted by C.J. Patterson Co.

3. Wisconsin Alumni Research Foundation (1955), Unpublisjed Report submitted by C.J. Patterson.

4. Hodge H.C., (1956), Unpublished Report dated 7 November 1956 submitted by C.J. Patterson co.

5. Hodge H.C., (1959), Unpublished Report dated 12 March 1959 submitted by C.J. Patterson Co.

6. Hodge H.C., (196O), Unpublished Report dated 2 August 1960 submitted by C.J. Patterson Co.

7. Hedge H,C,, (1955), Unpublished Report dated 17 June 1955 submitted by C.J. Patterson Co.

Karaya Gum

Description M-w --

Karaya gum is the dried exudate obtained from Sterculia, urens Roxburgh and of Sterculia (fem. Sterculiaceae), or from Cochlospermurn goss,ypium A.P, De species of Cochlospermum Kunth (fam. Bixaceae .

other species Condolle, or other

It is a complex, partially acetylated polysaccharide of extremely high molecular weight @a 9,50WWm Hydrolytic studies have yielded L-rhamnose, D-galactose and D-galacturonic acid in an apparent molecular ratio of 4:6:5. It has an acid number varying from 13.4 to 22.7 and tends to release acetic acid e.g. on storage. The Committee was irformed that the material on the market conforms with the specification in the Food Chemicals Codex, 1972, PO 423.

Technolo@.cal Application me-- N-M -w-w

Karaya gum has uses based primarily upon its cold-water-swelling and suspending properties. It has been used at about O.@$ level as a stabilizer for ice-cream and frozen drinks on sticks and at up to 1% level as a binder in sausage meat and bologna where it provides water retention and cohesive properties , giving a final product with a smooth appearance. It has also been used as a stabilizer for whipped cream products, and is used at up to 0.8% in cheese spreads to prevent water separation and increase the east of spreading. Karaya gum has also been used as a stabilizer in mayonnaise and French dressings where it functions by increasing the viscosity of the oil-water emulsion, thereby preventiw or slowing separation .

Toxicolo&cal Evaluation -1-e -- ---m-m

The Committee considered that this product was not acceptable for use in food on the basis of existing toxicological data. Establishment of an AD1 would require at least a metabolic study, a 90 day study in a rodent species and a long term study in an appropriate species. Beari% in mind the traditional usage of this substance in food, and provided the results

of the metabolic and 90 day study,become available tithin one year, the Committee would be prepared to reassess the present classification of this substance.

References ---L-I

1, Toxicological Monographs resulting from the Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives; WO Food Additives Series (1974)) No. 5, FA0 Nutrition

Meeti- Report Series, No. 53A, p. 324.

2. E3ctra Pharmacopoeia, Martindale, 25th Edition, The Pharmaceutical Press, London 1967.

Partial Poly&ycerol Esters of Polycondensed Fatty Acids of Castor Oil

DescriEtioy L-c--

Tne product is a highly viscous liquid, consists of a complex mixture of partial esters of polyglycerol with linearly esterified fatty acids derived from castor oil and conforms to the general formula:

OR

R- (OCR2 - CH - CH20)n - R

where R-H or a fatty acyl group derived from polycondensed ricinoleic acid and n = degree of polymerisation of glycerol.

It is prepared by the esterification of condensed castor oil fatty acids with polyglycerol. The polyglycerol is made by heating glycerol under vacuum pith a catalyst v:hilst the condensed acids are made by heating castor oil fatty acids in an inert atmosphere and have an average of about five fatty acid residues per molecule.

The polyglycerol moiety is predominantly di, tri- and tetra-glycerol. The Committee was informed that the toxicological evaluation was carried out on material canforming to the FA0 specification.

Technological Application -a.m,,d-,,- ati--

Polyglycerol esters of polycondensed fatty acids of castor oil are used for the production of water oil emulsions and as such are suitable for use in the baking trade as tin-greasing emulsions at a, maximum level of 50 parts per million. This emulsifier is also used in chocolate couverture (up to O.j$) or in block chocolate (up to 0.d) and it is claimed to be more effective than lecithin in lowering the viscosity of chocolate,

Toxicological Valuation --me m--w c--w

The Committee noted the development of hepatomegaly in the studies on rats fed a dietery level of 18$ of the above compound and noted that this effect was reversible. Furthermore, histpathological studies failed to reveal any significant abnormalities in the enlarged livers. The observed hepatomcgaly 1sas not associated with hyperplasia. The Committee established an AD1 of 7.5 mg/kg by:.

References m---c-

l.

2.

3.

Unpublished data submitted to UK Government by Unilever Ltd.

Toxicological Evaluation of 6ome Food Colours, Bnulsifiers, Stabilizers, Anticakinl; Agent8 and certain other Food Additives. FA0 Nutrition Meetings Report Series No. 46~, p. 105, WHO/Food Add/yCU6.

Toxicological Monographs resulting from the Seventeenth Report of the Joint FAO/WO EIxpert Committee on Food Additives, WHO Food Additives Series, (1974), No. 1, FA0 Nutrition Meetiws Report Series No. 53A, p. 246.

32

4.

5.

6,

7.

8.

9.

10.

11.

12.

13.

14.

Jenkins F,Pc, and Philp J.McL., (1961), Unpublished report of Unilever Research submitted to FAO/WJXO by Unilever Ltd.

Hatson W.C., and Gordon B.S., (1962), Biochem.Pha.riI&,*~,~p, 229.

Rutherford T., and Jones P., to FAO/WHO by Unilever Ltd.

(1967)) Unpublished report of Unilever Res. Labs,,

Labs.,

submitted

Kowes D., and James C.T., (1968)~ Unpublished report of Unilever Res. Labs,, submitted to FAO/yO by Unilever Ltd,

Jenkins F.Pe, and Philp J.McL*, submitted to FAO/WHO

(1968), Unpublished report of Unilever Res. Labs., by Unilever Ltd,

Jenkins F.Pr and Philp J&CL., (1967), Unpublished Report of Unilever Rese Labs., submitted to FAO/WHO by Unilever Ltd.

Wilson R., and Jenkins F.P., to FAO/wh'O by Unilever Ltd.

(1968), Unpublished report of Unilever Res. Labs., submitted

Kirkby I$., et al, (1969), Unpublished report of Unilever Res. Labs., submitted to FAO/NKO by Unilever Ltd.

Wilson R., Kirkby W1, and Philp J&CL., submitted to FAO/WHO by Unilever Ltde

(1967), Unpublished report of Unilever Reso Labs,,

Philp J.McL*, and Jenkins FoP., (1961), Unpublished report of Unilever Reso Labs., submitted to FAO/NHO by Unilever Ltd.

Philp J.NcL,, et al, (1961), Unpublished report of Unilever Res* La‘bs,, submitted to FAO/rWf-IO by Unilever Ltd,

i5. Wilson R., Kirkby Ii., and Ashmole R,, (1967), Unpublished report of Unilever Res. Labs., submitted to FAO/WO by Unilever i-t&,

16. Wilson R., Kirkby w., and kshmoie RI, (1967), TJ __ \TY\~-- submitted to FAO/WiIO by Unilever I,tc?*

rq,>b~ Ished report or Uniievey ResI Labs.,

17. Gellatly J.B.MI, and Jenkins F.P,, (1968), Unpublished report of Unilever Res. Labs., submitted to FAO/WO by Unilever Ltd.

. 18. Wilson R., Ashmo3.e R., and Gellatly J.b.l\l., (1968), Unpublished Fteport of Unilever Res, Labs., submitted to FAO/WHO by Urxilever Ltd,

19. Croger W,, Pnllp J.I<cL., and Wilson R., (1.968), Unpublished report of Uklever Res. Labs., submitted to FAO/WO by Unilever Ltd.

Sorbit an Nonopalmitate Sorbitan Monostearx Sorbitall Trj stearate Sorbitan I4oriolaurate Sorbi-tan Elono-oleate

Description w-w WV

The sorbit,an esters of fatty acids consist of t!~c partial esters of :;orbitol and its mono- and (ii-anhydrides k:ith pairnitic, stearic, lauric and olcic acids. l%Cy art? pr*ep,z:*?d by

tkc simple eotcrification of food-:;radc sorbltol wit 1; the nppl'opri;ite f<::ti-i:r,adc fatty uciri in tile presence oi an acidic catalyst at temperatures in the raw::c 225-25fi°C, Under these conditions internal ether formation as well as esterification takes place.

The Committee r~as informed that the toxicological cvnLuationsof sorhitan monnpalmit,ate all? sorbitan tristenrate were cerried out on material conforinin~, (r to the FA0 sp,ecific;tticnx, in the cese of eorbitan monostearate on material conformjq to the specifications in the Food Chemicals Codex 142, and in the cast of sorbitsn monol;Luratc and sorbit-tn mnn+-oleatc on materiais conforming to the specifications in the British Pharmaceutical Codex 1972.

Technological Applications ---m-w-- c--c-

The sorbitan esters of fatty acids are generally insoluble or dispersible in water and soluble in most organic solvents. These substances function both as emulsifiers and as anti-foaming agents, they are particularly useful for the production of wate-in-oil / emulsions.

They are used at levels of 0.4 to l.C$ as antibloom agents in chocolate and chocolate couverture and as batter aerating agents at levels of 0.3% to 0.4% in sponges, cakes and cake mixes.

The surface active properties of the sorbitan esters may be utilised in a number of mis- cellaneous applications. In particular, they are used to supress foam in liquid glucose/ sugar mixture or sucrose, and in the subsequent preparation of jams, preserves or boiled sweets, They are also used to prevent foaming of meat curing brines in modern high speed injectors. In each case the amount used is small and residues in the final product do not exceed 15-20 mg/kg.

In addition, the sorbitan esters are used to stabilizs flavour emulsions intended for use in soft drinks; levels in the final product do not exceed 150 mg/l.

~o,xi~o&o@~a& Evaluation ---m.-LL

Sorbitan Monopalmitate / Sorbitan Monxtearate / Sorbitan Tristearate:

The Committee endorsed the global ADIs established by JECFA of 25 me/kg bw for all three additives singly or in combination, calculated as aorbitan monolaurate,

Sorbitan Monolaurate / Sorbitan Mon*oleate:

The Committee reviewed the studies of Krantc and t!:ro nci-r short-term studies. On this evidence, the Committee established a global A31 of 5 mg,/kc bx for both additives singl<y or in combintation, calculated as sorbit an mono1a1wat,e~

References -CL--c- Sorbitan 14onopalmitate

1. Seventh Report of the Joint PAO/WO Expert Committee cn Food Additives; Wld.Hlth.Org,Techn. Report Series, (1964)~ 281, FA0 N t u rition Esetir~~s~ Series No. 3Jyyiio.

2. Toxicological Monographs resulting from the Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives, MO Food AdAitives Series (1974), No. 5; FA0 Nutrition Meetings Report Series Xc. 53A, p* 276,

3.

4.

Krantz J.C. jnr, (1947 _ ?, Unpublished report No. ~~~-149-126 to the Atlas Chemical Co.

Krantz J.C. jnr., (1947), Unpublished re,ncrt i~os.~,~R-l/t~171/201/232/232A/232B to the Atlas C?~omical Co.

5. Unpublishc:l report of the Atlas; GIC!YS -r?l Cc.

6. Schxartz L., Unpubli shed Report to the At1 2,:: %cmica! Co.

7. Unpubli shed report cl‘ t!;e Atl,!:; Glc:;lic,?! Co.

1.

2. Toxj cological Mcno~-rn??~s rcs1:l-t in,7 fro::: t!le SY. rllxtccntil Report 0-f the JolIlt FAO/WHO Expert Committee cn Food P,dditives; NH0 Food AMit ivcs Scrics, I.?eeti1~~s Rcpnr-t Series No. 53A, p. 278,

(lgd), No. 5, FA0 Nutrition

3. Krantz J.C. jnr., (1946)~ Unpublished report No. WIZR-14%lo2 to the Atlas Chemical CO,

4. Brandner J.D., (1973), Unpublished report submitted to FAO/WHO by ICI America Inc.

5. Krantz J.C. jnr., (195X), Unpublished report No. WEIR-149-315 to the Atlas Chemical Co,

6. Krantz J.C. jnr., (1947), Unpublished reports Nos. WE%14+187/245/245A to the Atlas Chemical Co.

7. Barboriack J.J., Krehl W.A., Cowgill G.R., and Whedon A.D., (1959), Unpublished report No. WER-149-454 to the Atlas Chemical Co,

8. Krantz J.C. jnr., (1945)) Unpublished Reports to the Atlas Chemical Co.

9. Butterworth K.R., (lv?), Unpublished Information from BIBRA.

Sorbitan Tristearate

1.

2.

3.

4.

5.

Seventh Report of,the Joint FAO/WHO tipert Committee on Food Additives; W'ld.Hlth.Org. Techn. Report Series& (1964), , FA0 Nutrition Meetiw Report Series No. 35, p. 110.

Toxicological Monographs resulting from the Seventeenth Report of the Joint FAO/MHO E=xpert Committee on Food Additives, WHO Food Additives Series, (1974), No. T1, FA0 Nutrition b1eetin:rs Report Series No._ 53A, p* 278.

Krantz J.C, jnr., (1947), Unpublished report No, HER-149-145 to the Atlas Chemical Co.

Krantz J.C. jnr., (1947), Unpublished reports Nos. MER-l@--172/202/230/23OA/2304 to the Atlas Chemical Co.

Barboriak J.J., Krehl W.Ao, Cowgill G.R., and Mnedon $aD,, (1959)) Unpublished report No. HER-143-454 to the Atlas Chemical Co*

Sorbitan Monolsuratc

1, Krantz J,C. jnr., Unpublished report to the Atlas Chemical Co.

2. Unpublished report of the Atlas Chemical CO.

3. Krsntz J,C. jnr-, Unpublished report to the Atlas Chemical Co,

4. Krantz J.C. jnr., Unpublished report to the Atlas Chemical Co.

5c Krantz J,C. jnr., Unpublished report to the Atlas Chemical Co.

6, Barbori,& J.J., Krehl W.A., Cowgill G.R., and Whedon A.D., (1959), Unpublished report No. WER-149-454 to the Atlas Chemical Co.

7. Butterworth K.R., Unpublichcd information from BIBRA, March 1977.

Sorbitan Mono-oleate

1. Toxicological rJionoGraphs resulting from the Seventeenth Report of the Joint FAO/VXO Expert Committee on Food Additives; WHO Food Additives Series, (1974), No. >; FA0 Nutrition Meetiwo Report Series No. 53~, p. 278

2. Krantz J.C. jnr., (19/17), Unpublished report No. WER-~L'J+~~O to the AtlaG Chemical CO.

3. Quigly A.D., (1968), Unpublished report, "Span CC-Acute Intravenous Toxicity in Rats",, of the Atlas Chemical Co.

4. Krantz J.C. jnr., (1950), Unpublished reports Nos. ~~R-14P-205/240/240A/2/10H ta the Atlas Chemical Co.

5. Ingram A.J., Butterworth K.R., Gaunt I$., Grasso P., and Gawolli S.D., (1977), Unpublished BBIBRA Research Report No. 2.

Polyoxyethylene (20) Sorbitan Eionolaurate Polyoxyethglene (20) Sorbitan Monppalmitate Polyoxyethylene (20) Sorbitan Monostearate Polyoxyethylene (20) Sorbitan Tristearate

Description -e---m

The polyoxyethylene sorbitan esters of fatty acids consist of the partial esters of sorbitol and its mono- and di-a@drides with palmitic, stearic, lauric or oleic acids, condensed with ethylene oxide.

Sorbitan esters of fatty acids are prepared by the esterification of food-grade soritol with the appropriate food-grade acid. These esters are then treated btith ethylene oxide in the presence of an alkaline catalyst at temperatures ranging from 130~170°C.

The Corzgittee had available the specification in (1964), of FAG for polyoxyethylene (20)

the Nutrition Meeting Report Series No. 35, sorbitan monopalmitate and the specifications in the

Food Chemicals Codex 15'72 for the other four polyoxyethylene sorbitan esters.

Technolo@cal ADplicatiocs -0I-m e.-L-W-rrra--

Polyoxyethyl en5 ao?bitaE esters of fatty acids function primarily as emulsifiers, although they have applica.+ion as softeners in bread, cakes and similar products. These substances are ge;lerall3, soluble or dispexible in water and differ widely in their solubilities in or emi c Colverits. Thzv arc parficrlarly effective in produciw oil-in--water emulsions. L

The Committee note:1 that duriq; the development of s-kin co-earcinogenicity tests, some s;Jecial pnlysorbates LJCTC used arx3 had been founi to -De we& promoters under these c=xperimental conditi 3x2. 16 concluded that- these observa'"ions had no relevance to the safety evalua%ion for food ;tdditive use of these substances.

5. Krantz J.C. jnr., (1947), Unpublished report No. h/ER-149-123 to the Atlas Chemical Co,

Polyoxyethylene (20) Sorbitan Monopalmitate

1.

2.

3.

Seventh Report of the Joint FAO/WHO Expert Committee on Food Additives; -Wldshith.Org, Techn. Report Series, , FA0 Nutrition Meetings Report Series No, 35, p. 140.

Toxicological Monographs resulting from the Seventeenth Report of the Joint FAO/WO E=xpert Committee on Food Additives, 'WHO Food-Additives Series (1974), No, l9 FA0 )Jutrition Meetinp Report Series No, 53A, pa 254.

Treon J.F., Gongwer L.E., Nelson I&F,, and Kirschman J.C., Application of surface active substances, p* 381, Vol.111 of Chemistry Physics and Application of surface active substances, Gordon and Breach, New York 1196710

Polyoxyethylene (20) Sorbitan Mono&ear&e

1, Seventh Report of the Joint FAO/WHO EScpert Committee on Food Additives; Wld,Hlth.Org. Techn. Report Series, ; FA0 Nutrition Meemort Series hro, 35, p. 140,

2. Toxicological Monographs resulting from the Seventeenth Report of the Joint FAO/WHO Expert Commit-tee on Food Additives, WIO.Foo-d Additives Seriesl (1974)p m; FA0 Nutrition Meetings Report Series No. 53A, P C 254.

38 Treon J8F., GoreTer L,E8, Nelson X,F,, anr? Kirschman J8Ca, ApPlication of surface active substances, p. 381, Vol. III, of Chemistry, I%vsics and Application of surface active substances, Gordon and Breach, New York, , '1967).

48 Krantz J.C. jnr., (1947), Unpublished reports Nos8 ~R-l4~164/133/23S/A~~ to the Atlas Chemical Co,

5. Krantz, J8C8 jn..r8f (1949), Unpublished report NO, '&3R~i4~2?O/A/$I to the Atlas Chemical Co,

6, Krantz J.C, jnr., Unpublished Report to the Atl,-,$ %-ie::iica1 Co,

7. Krantz J.C. jnr,, JTusser R,D,, alld Knapp NyJ*, (19523, Proc,Soc,Ex~~niola and El&,, & pe 640.

8, Delia porti G,, Terracic B., Dmier-t K., and Shubik Pa, (1960), J&XZ=Canc*Ins&, 3, P. 573-605.

Polyoxyethylene (20) Sorbitan mono-oleate

1, Seventh Report of the Joint FP_O/hEO .&:pert Committee 011 FOG; Addjtives; Hld,Elth.Or&* Techn. Report Series, ; FA0 %.rtriti.on Meetiq;s Report Series No. 35, pq 140.

2. Toxicological Monographs resulting from the Seventeenth report of the Joi.& FAO/mO Expert Committee on Food Additives, Ml0 Food Additive Series, (ls,4), No. 5? FA0 Nutrition Meetirys Report Series No. 53A, p* 254.

3. Treon J,F., Gow:er T,.E., N(:lso!~ N-F,, an-? Kirs;c:hln;ln J.C., Arb;,licatioll of surface active substances, p. 381, Vol. III of Chemistry P1iysic.s and -4ppl1 cation of surfe&ce active substances, Gordon and Breech, New k-or+-, t19w.

5. Krantz J.C. Jnr., (19(13), Unpllblishec! rep0r.t I;(,. tiEiI-li4&\?1 t (; tlie Atlas c.'lcoiical CO.

6. Krantz J.C. jnr., (1947), UnpLlIJlished re~)!?rt Xo. E3?-?~3-!33 t.cT t11c Atlas '.Z~cmisai Co.

7. Dubos R.J., ( 1949), Unpublished data, reported in record oi‘ hearings on definition and standard for bread. F.D.C. Docket No. 31(b), September 12.

Polyoxyethylene (20) Sorbitan Tristearate

1. Seventh Report of the Joint FAO/WHO Expert Committee on Food Additives, Wld.Health.Org, Techn.Report Series, (1964), 281, FA0 Nutrition Meetings Report Series No. 35r p* 140.

2. Toxicological Monographs resulting from the Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives, WHO Food Additives Series, (1974), No. 2, FA0 Nutrition Meetings Report Series No. 53A, p. 254.

3. Treon J.F., Gongwer L.E., Nelson M.F., and Kirschman J.C., (1967), Application of surface active substances, p. 381, vol. III of Chemistry, Physics and Application of surface active substances, Gordon and Breach, New York.

4. Krantz J.C. jnr., Unpublished Report No. WER-149-153 to the Atlas Chemical Co.

5. Krantz J.C. jnr., Unpublished Report to the Atlas Chemical Co.

Polyoxgethylene (8) Stearate Polyoxyethyl ene (40) St earate

Description -B---B

The products are composed of partial esters of stearic acid derived from food fats and mixed polyoxyethylene diols.

The structural formulae of the principal components are:

free polyol monoester diester

Where RCOO is the fatty acid moiety and n has an average value of approximately 7e5 in the case of Polyoxyethylene (8) stearate and 40 in the case of Polyoxyethylene (40) stearate. The Committee was informed that the toxicological evaluations were based on materials confom- ing to the FA0 specifications.

Technological Application ----a-- ----e-

These two esters are used in bread, rusk, biscuits and other baked foods to improve shelf-life.

_To~icolo@cal Evaluation m... -- ---m-m

The Committee reviewed the available data in experimental animals and established a temporary AD1 of 25 mg/kg bw for Polyoxyethylene (40) t s earate but the Committee requires a metabolic study and a 90 day study in a rodent species to become available within 2 years.

In the case of Polyoxyethylene (8) stearate, the Committee requires two studies to be available within 4 years. One to elucidate the mechanisms of stone formation in the urinary bladder, the other to be a conventional long term study. In the former, the Committee would expect to receive interim reports. Meanwhile, the Committee considers the use of this substance temporarily acceptable.

References --w-w-

1.

2.

3.

Rirkmcer R-L., and Branc1ner J.D., (1958), Rpric. and Food Chem., 6, p. 471.

Seventh Report of the Joint FAO/h?ICl Expert Committee on Food Additives; h7d.Hlth.Or~. Techn. Report Series, (1964), a, FA0 Nutrition Meetings Report Series No. 32, p. 124.

Toxicological Monographs resultiv from the Seventeenth Report of the Joint FAO/WIO Expert Committee on Food Additives, WHO Food Additives Series, (1974), No. 5, FA0 Nutrition Meetings Report Series No. 53A, p. 264.

I

4. Oler W.M., and Craemer V.C., (1955), Gastroenteroloa, 28, p. 281.

5. Graham W.D., Teed H., and Grice H.C., (1954), J. Pharmacol., 6, p. 534.

6. Graham W.D., and Grice H.C., (1955), J. Pharmacol., 1, p. 126. .

7. Krantz J.C. jnr., (1947), Unpublished report No. WER-149-122 to the Atlas Chemical CO,

Glyceric Esters of Fatty Acids obtained from Soya Oil Oxidised under heat

Description -c-III

The nomenclature in.connection with commercially available mixtures is complicated and the following classes have been suggested to the Committee by the manufacturers:

A. Oxidatively thermally polymerised Soya Bean Oil.

B. Oxidatively thermally polymerised Soya Bean Oil interacted with mono- and di-glycerides.

C. Oxidatively thermally polymerised Soya Bean Oil interacted with triglycerides.

It was noted that in compound B a small percentage of triglycerides is present.

Technological Application -O.--L,,,, ---I

The Committee was informed that mixtures falling into cl ass A are used primarily in tin greasing emulsions and are excluded from the scope of the Directive 74/329/EEC.

Mixtures falling into classes B and C are used as emulsifying and anti-spattering agents in particular for protein containing margarine, (e.g. those containing milk solids in the aqueous phase) at a level of use of 0.3 to 0.3; (maximum).

Toxicolopical Evaluation ,,,,i,, -----am

The Committee was provided !+ith a report of metabolic studies on mixtures of class B in the rat , guinea-pig and mouse. A specification has also been provided which limits, in particular, the temperature range for the polymerisation of the soya bean oil to bet:+:een 19 and 200OC. The Committee b:as unable to establish an AD1 but agreed that mixtures of class B could be temporarily acceptable for use in food for 5 years, This will allow time for the completion of a g-day study in the rat and a long term study in a rodent species.

References ---a--

1.

2.

3.

4.

5.

6.

Unpublished information submitted to the Commission of the European Communities through the Danish Government by Grindstedvzrket, Denmark, December 1977.

Toxicological evaluation of some enzymes, modified starches and certain other substances; '3HO Food Additives Series No. 2; FA0 Nutrition Meetiws Report Series No, ?OA, (1972), ~8 67.

Toxicological evaluation of some food additives incll~~!ir,; antic;&ing qents, antimicrobials, antioxidants, emulsifiers and thickening agents; WO Food 4dditives Series No. 2; FA0 Nutrition MeetivLs Report Series, No. 53A, (lgd), pa 225

Unpublished Report of the British Industrial Diolq:ical Research Association (B~BII;I) m70) 1 submitted to the Commission of the European Communities throue;h the Danish Government by Crindstcdv,xrket, Denmark.

Dam, H., (1952), Unpublished Report submitted to the Commission of the European Communities through the Danish Government b:{ Crin4stetlvsrket, Denmark.

Aaes-Jorgensen E., F'unch J.P., Engel P.F., and Dam II., (1954), Ilnpublished Report submitted to the Commission of the European Communities through the Danish Government by Grindstedvzrket, Denmark.

7. Gyrd-Hansen N., and

8. Harmsen H., (1961), Communities through

Ghatti Gum

Description ------

Rasmussen F,, (1968), Fd.Cosmet.Toxicol., 6, p. 163.

Unpublished report submitted to the Commission of the European the Danish Government by Grindstedvaerket, Denmark.

Gnatti gum is an amorphous translucent exudate of the Anogeissus latifolia tree of the family Combretaceae. This is a large tree found in the dry deciduous forests of India and Ceylon. The gum exudate occurs in rounded tears and has a glassy fracture. Its colour varies from very light brown to dark brown with the lighter material yielding a better grade of gum.

Ghatti gum is basically the calcium salt of an acidic polysaccharide, ghattic acid. The purified acid has an equivalent weight reported to be between 1340 and 1735, however more recent studies have indicated that ghatti gum is a heterogeneous poluymer. Fractionation by alcoholic precipitation or by chromatographic separation on silica gels yielded three fractions with equivalent weights of 1750, 1800 and 2040,

The Committee was provided with the specification for ghatti gum laid down in the UK Emulsifiers and Stabilizers in Food Regulations 195, S.1, 1975 No. 1486,

Technological Applications ------ -- -w--L-

Ghatti gun has been utilised in foods as an effective emulsifier for oil-in-water emulsions, In addition, the gum acts as a natural buffer and small amounts of acid or alkali will not affect it, It has been used as an emulsifier and stabilizer in maple syrups containirg butter for use on pancakes a.4 waffles.

Toxicolopical Evaluation l.-.m.,~ --r--c- --s.-

The Committee considered this compound toxicologically unacceptable for use in food on the basis of existing data. The compound should be phased out, unless a definite assurance b:as received that within 4 years the follocing studies would be available for assessment: 7 IP Metabolic studies in 2 species.

2. w-day studies in a rodent and non-rodent.

3. A long~-term study in the rat.

4* Studies on the allergic response, if known, in animals and man.

5. Data on intake from food and other sources,

References -w-v--

l* Elsworthy P.R., and George TJlo, (1963), J. Pharm. Pharmacol., IJ, p. 781

Xanthan Gum

Description w-w we

Xanthan p is a hi,:f: molecular weit:ht (1,OOO,OOO) linear pol,ymer wit:? a.>-linked backbone containiw D-g:lucosc, &nannr>sc,

f and IL~lucuronic acid \;ith one D-mnnnooc side-chain llnit

for every 8 suy;;s- rcsitiucs ,qr~l one IL~;lucose side-chain fhr every 16 sufr:\r residues. Tne polyoaccharicie ir; ;)ari,ial!~y acetylntcfl. and contains tjet;:ccn 3.0 nnri 3.7;: pyruvic acid. The molar ratio Il-,~lucose: Tknannosc: %glucuronic acid is 1.4: 1.0: 1.0.

Technological Applications ---L-I m-w- ---w

Xanthan gum functions as a hydrophilic colloid. Nether pH nor temperature have much effect on the viscosity of solutions of xanthan gum. It is soluble and stable in acid and alkaline solutions, and in solutions containing high concentrations of various salts. The gum is soluble in hot or cold water and is heat stable, even at very high temperatures. Solutions of xanthan gum have extreme pseudoplasticity (high viscosity under low shear but low viscosity under high shear) and high viscosity at low concentrations.

It is used at up to approximately 0,s in a variety of foods such as sauces and salad dressings, instant puddings, milk drinks and dairy products.

Toxicological Evaluation Cl-- --c ----II

The Committee was informed that the toxicological evaluation was carried out on material conforming with the FA0 specification. The Committee considered the available toxicological 10 mg/kg bw.

information to be adequate and endorsed the AD1 established by JECFA of

However, the Committee drew attention to the fact that in its opinion a specification for Xanthan gum should also prescribe that no viable micro-organisms should be present and that the nitrogen content of Xanthan gum should be controlled by stipulating, in the specification, a maximum nitrogen level.

References -----I-

l.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

Technical bulletin on "Keltral" (Xanthan gum), Kelco CO., San Diego, California, USA.

Toxicological El"onographs resultin? from the Eighteenth Report of the Joint FAG/M30 Er,pert Committee on Food Additives, WHO Food Additives Series, (1975)$ No. 6, FA0 Nutrition Meetings Report Series ru'o. 55, p. 155.

Booth A.&, Hendrickson A.P., and Deeds F., (1963)) Tosicol.Appl,Piiarmacol.~~, p. 478,

Gumbmann i%.R., Research Report, (Xanthan ~~~~), by the Rat",

(1964), '%Setabolism of Carbon-14 Polysacchnride, Ir-1459, of the Western Regional Research Laboratory, submitted to

JECFA by Kelcc Co., San Diego, California, USA.

Hendrickson A.P., and Booth A.N., Research Repcrt (1964), "Supplementary Acute Toxicological Studies of Polysaccharide %1459", of the Western Regional Research Laboratory, submitted to JECFA by Kelcc Co., San Diego, California, USA.

Durloo R., Woodard !.l.W., and Woodard G., Research Report (1968), "Xanthan Gum, Acute Oral Toxicity to Rats" of the Woodard Research Corporation, submitted to JECFA bJ Kelco Co., San Diego, Califorr;ia, USA.

Jackson FJ.N., Woodard I*I.!:[., and Woodard G., Research Report (1968), "Xanthan Gum, Acute Oral Toxicity to Dogs", of the Woodard Research Corporation, submitted to JECFA by Kelco Co., San Diego, California, USA.

Robbins D.J., Moulton J.E., and Booth A.N., (1964), Pd.Cosmet.Toxicol., 2, p. 545.

Booth A.N., an4 Eoulton J.E., Research Report (1965), "%afety Evaluation of Polysaccharide irl459 (Xanthan gum) in Laboratory Animals" of the Westerll Regiona!. Research Laboratory, submitted to JECFA by Kclco Co., San Diego, Californi:', USA.

Wooiinrl G., Lioo:i;~rd ;.:.W., McIjeely W-II., Kovacs P., and Cronin LI.T.I., (lyfj), Toxicol. &j31.PkmI1acol., 2, p. 30.

Howard D.J., Bancrjec B.IJ., Woodard M.W., and Wooclard G., Research Report (igG8), "Xant1lan Gum, Safety Evaluation by Oral Administration to Rats for 104-105 weeks", of the Woodard Research Corporation, submitted to JECFA by Kelco Co., San Diego, California, USA.

12, Banerjee B.N., Rawlins G., Doncso J., W00dard M.W., and Woodard G., Research Report, (1968), "Xanthan Gum, Safety Evaluation by Oral Administration to Dogs for 107 weeks",. of the Woodard Research Corporation, submitted to JECFA by Kelco Co., San Diego, California, USA.

13. Leigh C., Shaffer B.C., Woodard M.W., and Woodard G,, Research Report (1968), "Xanthan Gum, Three Generation Reproduction Study in Rats, of the Woodard Research Corporation, submitted to JECFA by Kelco Co., San Diego, California, USA.

Extract of Quillaia

DescriEtLo_n LII

Qcllaia is the dried inner part of the bark of Quillaia saponaria Molina and of other species of Quillai?.

Quillaia extract is an aqueous extract of the dried inner part of the bark of Quillaia SaPonariaMolina and other species of four saPonZY@o major,

Rosaceae) and contains three or possibly about lO$ of the extract.

The sugamglucose, galactose, arabinose, xylose, rhamnose and two further unidentified sugars are also present. The two major saponins are quillaia sapogenin which has a triterpenoid structure and quillaic acid*

The Committee was informed that the toxicological evaluation was carried out on natural extract of quillaia bark as specified in the British Pharmacopoeia 1973.

Technologicai Application --m-w --- ---I

Quillaia. extract is used in the soft drink industry to give a good head of foam in ginger beer, shandy, cream soda and lemonade. Tnese products may contain up to 200 ppm of the dry matter content of the extract. The spray dried aqueous extract of quillaia bark is prepared in such a manner that 100 parts by weight of bark yield approximately 15 parts of spray dried extract*

Toxicolo@cal Evaluation -,,,L,, --1.d,--

The Ccmmittee considered in detail the composition of this product, its pharmacological properties, the source of the material, and the results of two lone-term studies in the mouse and rat. For the sPray-dried extract the Committee established an AD1 of 5 mg/kg bw, /

References w---w-

1. Vacek L., and Sedlak B., (x962), Gunma J.Med.Sci., 11, P* 10

2. George A.J., (1965), pd.Cosmet.Toxicol., 21 Pa 8.5.

3. Peterson D.A., (1950), J.Nutr., &?, PO 597.

4. Osor B.L., (1966), Fd.Cosrnet.Toxicol., 4, P* 57.

5. Gaunt I.F., Grass0 P., and Gangolli S.D., (1974), Fd.Cosmet.Toxicol., l2, p. 641.

6. Rutterworth K.R., (1.97), mile results of an 84 we& study in mice with Quillaia extract, vnpublished information from BIHA, 14arch 1977.

7. Lutterworth K.R., (1977), Tine results of a ion,-term toxicity study of Quillaia extract in the rat, Unpublisil& infonllation from ETRRA, &iarci~ 1977.

Lactylated Fatty Acid Esters of Glycerol and Propylene Glycol

_Dezcrigtio,n

A mixture of partial lactic and fatty acid esters of propylene glycol (propane-1,2-dial) and glycerol produced by the lactylation of a product obtained by reacting edible fats or oils with propane-1,2-dial. solid.

It varies in consistency from a soft solid to a hard, waxy

benzene, It is dispersible in hot water and is moderately soluble in hot isopropanol,

chloroform and soya bean oil.

The Committee was provided with a specification for lactylated fattyacidesters of glycerol and propylene glycol from the Food Chemicals Codex 1972,

The lactylated fatty acid ‘esters of glycerol and propylene glycol are used in cake shortenings to improve texture and volume in the baked goods, in powder desserts and whipped toppings to improve whippability and stability and in dessert mixes to improve consistency and stability of pudding and other similar products. The main use is in whippable fat powders, which are used to make synthetic creams, desserts and dessert mixes.

Toxicological Evaluation -L-I m--w W-L-

The Committee was of the opinion that the specification should restrict the content of propylene glycol dimers and trimers to a maximum of O,'j$. It considered the compound temporarily acceptable for use in food, but requested a metabolic study and a gc)--day study in a rodent species vrithin 2 years,

References --c--L-

1. Lactylated fatty acid esters of glycerol and propylene glycol, A Report Pretlared for JECFA, 1973.

2. Wolf c., Fancher O.E., and Calsndra J.C., (13673, Unpublished Report, "90 day SubacuteOral Toxicity of PGLS - Albino Rats" of Industrial Bio-Test Laboratories Inc.

3. Baran J., Fancher O.E., and Calandra J.C., (1967), Unpublished Report, "!?O-day Subacte Oral Toxicity of PGLS - Beagle Dogs" of Industrial Bio-Test Laboratories Inc.

Dioctyl Sodium Sulphosuccinate

DcscriEtion c-w --

Dioctyl sodium sulphosuccina-te may be produced by esterifying maleic anhydride with 2-ethyl hexanol and treating the product with sodium hydrogen sulphite.

The Committee was informed that the toxicological evaluation was carried out on material conforming to the FA0 specification, 1975.

Technolo$zal Apnlications ---cI -O.&cm. CII

It has been claimed that dioctyl sodium sulphosuccinate (DSS) has useful properties in the food industry as a solubilizer for various hard-tc+k:et substances. These include fumaric acid and various natural and synthetic pn:; :/hi& form hydrophilic colloids. Applications of DSS to poi;dcrcd mntcrialr, at levels of about O.y,:!, by \:eight causes marked changes in the solubility characteristics of the materials.

It is used as a procecsiw aid in the sugar industry. DSS is also used as a flavour and aroma modifer. h'hen used at lcvcls of about 10 ppm in the final food, many taste qualities are altered, e.g. citrus flavours are enhanced. At this low level the bitter taste of DSS itself is not detectable. This bitter taste is a self-limiti% factor which would not normally allot! quantities greater than 50 ppm DSS to be used in food and still give a palatable produce.

~o~icolo@cal Evaluation I- CI ---IL-

The Committee established a temporary AJX of 081 mg/kg bw. The results of a long-term study in a rodent species are required within a period of 4 years.

References ----LIm

1.

2e

3.

48

5.

6.

7.

Technical Bulletin on 'rComplemix" (Dioctyl sodium sulphosuccinate) supplied by the American Gyanamid Company.

Toxicological Monographs resulting from the Eighteenth report of the Joint FAO/WHO Expert Ccmmittee.on Food Additives; FA0 Xutrition Meetings Report Series No. TTp, WHO Food Additives Series No.. .6, (1976), pI 175.

Taylor R.E*, (1966), Unpublished Report from Harris Laboratories, submitted to JECFA.

Fitzhugh O.G., and Nelson A.A*, (1948), J.AmePharmcAssoco, 3'& p. 29.

Benaglia AZ., Robinson E.J., PO 175.

Utley E., and Gleverdon M.A., (1943), J.Ind&,Tox., 3,

Eighteenth Report of the Joint FAO/WHO Expert Committee on Food Additives; FA0 Nutrition Meetings Report Series No, 54, WHO Technical Report Series No, 'j/l, p. 24,

Moffat R.Ee, Kramer LcLc, Lerner D., and Jones Ro, (19’75), Can.J. Comp.Med., 39, p.434.

A.m~~onium Phosphatides

Description oecwI)L--

AXLEIO~~.UIII phosphatides consist es:;entially of a mixture cf the ammonium salts of phosphatidic acids derived from edible fat (usually partially hardened rapeseed oil). They are similar in composition to commercial lecithins and consist of approximately 60,, phospholipids and 4s unreacted triglyceride.

The Committee was informed that the material toxicologically evaluated for use in foodstuffs conforms to t'ne manufacturer's specification and may be described as a mixture of ammonium salts of phospha-tidic acids derived from rapeseed oil, with a proportion of triglycerides from the part ially-hardened oil, The impurities did not exceed 0.2$ water, 2.5$ matter insoluble in light petroleum (b.p. @--SOOC), 0.2;; inorganic matter insoluble in light petroleum (b,p. 40-60°C), 4% unreacted triglyceride, 3.0-3.4$ phosphorus, 2.5 ppm arsenic, 2 ppm lead and 2 ppm copper; the pH of the mixture was between 6 and 8,

Technolo$.cal ApElicaticns ---a m-w -w--w

Ammonium phosphatides are used principally in the manufacture of chocolate at a level of approximately 0.s.

Toxicolo@cal Evnlustion -w-w --I -c--m

The Committee established an AD1 of 30 mc;/kg bw.

References w--m -c

1. Bradford L., (1976), Intcrh.otional Fr+:rxnces and Flavour, Jj. 177.

2. Toxicological Monoqnpfls resulting fro:]: the Eighteenth Report of the Joint FAO/WHO I&pert Committee on Food Additives1 F-40 Nutrition 1l;eetinp;s Report Series TJn. 52; NH0 Food Additives Series No. 6, (196 .

3. Frazer A.C., (1954), Unpublished report submitted to JECFA.

4. Feuer G., (1967), Fd.Cosmet..Toxicol., 2, ~4 631,

5. Gaunt I.F., Grass0 P., and Gangolli S.D., (1967), Fd.Cosmet*Toxicol., 2, p. 623,

6. Branton P.G., Gaunt I.F., Hardy J., Grass0 Pa, and Gangolli S.D., (1973), Fd.Cosmet, Toxicol., 11, I?* 755.

7. Philips J.C., Gaunt I.F., and Gangolli S.D*, (1%'5), Fd.,Cosmet.Toxicol., 23, pI 2je

8. Unpublished Report NO, 123/l/75 from BIBRA to Cac%ury Ltd., Bourmille, England, 1~75.

European Communities - Commission

Reports of the Seventh series

Scientific Committee Food

Luxembourg: Office for Official Publications of the European Communities

1978 - 46 p. - 21 x 29,7 cm

DA, DE, EN, FR, IT, NL

ISBN 92-825-0790-4

Catalogue number: CB-NW-7%007-EN-C

BFR 55 DKR 9,60 DM 3,50 FF 7,80 LIT 1470 HFL 3,80 UKL 0.90 USD 1.80

The Scientific Committee for Food was established by Commission Decision 74/234/ElX of 16 April 1974 (OJ No. L 136 of 20.5.1974 page 1) to advise it on any problem relating to the protection of the health and safety of persons arising from the consumption of food, and in particular the composition of food, processes which are liable to modify food, the use of food additives and other processing aids as well as the presence of contaminants.

The Members are independent persons, highly qualified in the fields associated with medicine, nutrition, toxi- cology, biology, chemistry, or other similar disciplines.

The present series relates to opinions on certain aspects of the Directive on Emulsifiers, StabiIizers, Thickeners and Gelling Agents for use in Foodstuffs (74/329/EEC of 18 June 1974, OJ L 189 of 12.7.1974, p. l), in partic- ular the acceptability, from the point of view of safety in use, of substances listed in Annex II of the Directive.